Pinch clip occluder for infusion sets

ABSTRACT

A pinch clip occluder for infusion sets is disclosed including a housing and a clamp movably disposed within the housing to selectively occlude an infusion set. In one embodiment the clamp has at least one arm which moves between first and second positions to pinch closed a silicone tube of the infusion set unless the pinch clip occluder is held in an open position by the user, or placed in a receptacle which will hold the pinch clip occluder in an open position. In another embodiment a plunger is disposed so as to intersect a passage passing through the housing. As the plunger is selectively moved between first and second positions, the flow through a tube in the passage is selectively controlled. Such an arrangement prevents a free-flow condition from occurring through the infusion set.

This application is a divisional of application Ser. No. 08/410,912filed Mar. 27, 1995, abandoned.

BACKGROUND OF THE INVENTION

The present invention relates to an occluder device for theadministration of enteral and/or parenteral solutions, and in particularto a pinch clip occluder for infusion sets.

The use of infusion sets to administer solutions to patients is wellknown in the medical arts. Infusion sets are used for both enteral andparenteral applications. Enteral feeding pumps are used to providepatients with nutrition and medication when they are unable, for avariety of reasons, to eat normally. Parenteral (intravenous) solutionsare provided to patients to ensure adequate hydration and to provideneeded nutrients, minerals and medication. Often, the infusion set isplaced in a free standing arrangement in which gravity forces thesolution into the patient. The rate at which the solution enters thepatient can be roughly controlled by various clamps, such as rollerclamps, which are currently available on the market.

In many applications, it is necessary to precisely control the amount ofsolution which enters the patient. When this is the case, a regulatingdevice, such as an enteral feeding pump, is placed along the infusionset to control the rate at which the solution is fed to the patient. Inapplications where a pump, etc., is used, the clamps used to regulateflow are typically manually opened, when employed, as they may interferewith the proper functioning of the pump. When used, the roller clamp maybe closed to stop flow through the infusion set with the intention thatthe medical personnel will momentarily connect the pump or otherregulating device to the infusion set. However, emergencies or otherdistractions may prevent the medical personnel from properly attachingthe pump or other regulating device or properly operating the clamp.

When the infusion set is not properly positioned in the pump, etc., asituation known as free-flow often develops. The force of gravity causesthe solution to flow freely into the patient unchecked by the pump orother regulating device. Under a free-flow condition, an amount ofsolution many times the desired dose can be supplied to the patientwithin a relatively short time period. This can be particularlydangerous if the solution contains potent medicines and the patient'sbody is not physically strong enough to adjust to the large inflow ofsolution.

Thus, there is a need for a device that prevents a free-flow conditionif the infusion set is not properly mounted in the pump or otherregulating means.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a safety occluderfor infusion sets which prevents an accidental free-flow condition.

It is another object of the present invention to provide an occluderwhich is simple to make and use.

It is another object of the present invention to provide such anoccluder which is inexpensive and thus disposable.

The above and other objects of the invention are realized in a pinchclip occluder biased in an occluding position to prevent free-flowconditions. In one embodiment of a pinch clip, the occluder includes ahousing with a passage therethrough and a pinch clamp nestable in thehousing. The pinch clamp includes arms which are typically biased in aclosed position when no external force is acting thereon, but may bemoved into an open/nonoccluding position by movement of the clamprelative to the housing.

In another illustrated embodiment, the occluder includes a housing witha passage therethrough for receiving a delivery set. A plunger disposedalong the housing is movable between two positions, one of whichoccludes flow through the delivery set and the other of which allowsflow through the delivery set. To overcome the risk of a free-flowcondition, the plunger is typically biased in an occluding position.

In accordance with one aspect of the invention, a biasing member, suchas a spring, is disposed between the housing and part of the plunger orpinch clamp to bias the plunger or pinch clamp in a closed positionuntil the infusion set is properly mounted in a flow regulating device,such as an enteral feeding pump.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects, features and advantages of the inventionwill become apparent from a consideration of the following detaileddescription presented in connection with the accompanying drawings inwhich:

FIG. 1 shows a perspective/exploded view of the pinch clip occluder madein accordance with the principles of the present invention;

FIG. 2 shows a perspective view of the pinch clip of FIG. 1 mounted in areceptacle for maintaining the pinch clip in an open position, and afragmented view of an infusion set passing through the pinch clip;

FIG. 3A shows a side cross-sectional view of a pinch clip occluder madein accordance with the principles of the present invention, and disposedin an occluding mode;

FIG. 3B shows a side cross-sectional view of a pinch clip occluder madein accordance with the principles of the present invention, and disposedin a nonoccluding mode;

FIG. 4 shows a cross-sectional view of another embodiment of the presentinvention.

FIG. 5 shows a perspective view of yet another embodiment of the presentinvention;

FIG. 5A shows a side cross-sectional view of the embodiment shown inFIG. 5; and

FIG. 6 shows perspective view of the embodiment of the inventiondiscussed regarding FIGS. 5 and 5A positioned in the housing of anenteral feeding pump.

DETAILED DESCRIPTION

Reference will now be made to the drawings in which the various elementsof the present invention will be given numeral designations and in whichthe invention will be discussed so as to enable one skilled in the artto make and use the invention. Referring to FIG. 1, there is shown anexploded view of a pinch clip occluder for infusion sets, generallyindicated at 2. The pinch clip 2 includes a clamp 8 having a base 12with a flange 14 around the bottom of the base. A pair of pincher arms16 extend from the base 12 opposite the flange 14. A passage 20 in thebase 12 enables a tube of an infusion set, not shown, to pass throughthe base, and between the arms 16. The arms 16 are biased in a closedposition so that a pair of heads 24 (one on each arm) are sufficientlyclose together to occlude a tube of an infusion set passing between theheads, i.e. pinching sides of the tube of the infusion set togetherbetween the heads so that solution cannot flow through that portion ofthe tube.

The pinch clip 2 also includes an adjustment means in the form of ahousing 30 formed by a generally cylindrical wall 32. The housing 30 isdesigned so that the clamp 8 will fit inside a hollow 34 extendingthrough the housing. The hollow 34 begins at an open first end 36 of thehousing 30 and terminates at an open second end 38 of the housing 30 ina passage 42. When the clamp 8 is nested in the housing 30, the passage42 in the second end 38 of the housing is in axial alignment with thepassage 20 in the clamp. The axial alignment of the two passages 20 and42 allows the tubing of an infusion set, not shown, to be passed throughthe pinch clip 2.

The housing 30 has a pair of channels 48 formed in at least one positionalong the wall 32. The channels 48 are designed to receive projections52 extending outwardly from each head 24 on the arms 16. The channels 48are sloped so that lower ends 56 of the channels are separated from eachother by about the same distance as the heads 24 of the arms 16 when inthe biased, closed position. Thus, when the projections 52 are disposedat the lower end 56 of the channels 48, the arms 16 remain in theirbiased state and preclude fluid from passing through an infusion setpassing therethrough.

The upper ends 60 of the channels 48 are disposed further apart than thelower ends 56. Thus, if the clamp 8 is pushed upwardly into the housing30 so that the projections 52 move from the lower ends 56 of thechannels 48 to the upper ends 60, the projections 52, the heads 24 andthus the arms 16 are forced apart, overcoming the biasing of the arms.When the projections 52 are disposed at the upper end 60 of the channels48, the heads 24 of the clamp 8 are held apart sufficiently that fluidcan flow freely through the infusion set.

Also shown in FIG. 1 is a spring 70. The spring 70 is positionedadjacent the base 12 of the clamp 8 so that the bottom of the springrests on the base. When the clamp 8 is nested in the housing 30, the topof the spring 70 rests against a lip 76 below the channels 48. Thenatural bias of the spring 70 is to push the clamp 8 out of the housing30. The clamp 8, however, cannot be totally pushed out of the housing30, because the projections 52 catch at the lower ends 56 of thechannels 48. Thus, the spring 70 biases the clamp 8 into a position inwhich the heads 24 on the arms 16 will occlude an infusion set passingtherethrough. When the clamp 8 is pushed into the housing 30, overcomingthe force of the spring 70, the arms 16 will spread further apart as theprojections 52 follow the channels 48 to the upper ends 60.

Referring now to FIG. 2, there is shown a perspective view of the pinchclip 2 disposed in a receptacle 80 formed as a half cylinder. In orderto place the pinch clip 2 into the receptacle 80, the clamp (disposedwithin the housing) must be pushed into the housing 30 sufficient forthe bottom of the housing to touch the flange 14, or be positioned veryclose thereto. When the clamp is in such a position, the projections 52are forced to the upper ends 60 of the channels 48 so that the heads(not shown) do not occlude the infusion set 86. Such a receptacle 80will typically be formed in devices such as enteral feeding pumps (notshown) which receive an infusion set, rather than being formedseparately. No solution can flow through the infusion set 86 unless thepinch clip 2 is properly placed in the receptacle 80. Thus, medicalpersonnel cannot accidently create a free-flow state by forgetting tothread the infusion set 86 through an enteral feeding pump, because thepinch clip 2 will occlude flow unless properly mounted in the receptacleof the feeding pump. If the infusion set is accidentally pulled out ofthe pump, the pinch clip 2 will automatically spring into an occludingposition, thereby preventing free-flow of the solution.

Those skilled in the art will recognize that each component of the pinchclip 2 and the receptacle 80 could be made of numerous differentmaterials. However, it is anticipated that the all of the structures,except the spring 70 (FIG. 1) will be made of polyvinylchloride (PVC),or polycarbonate materials which are inexpensive and easy to fabricateinto the structures described. Such materials would also make the pinchclips 2 disposable. If greater durability is desired, materials such asadvanced engineering plastics or metal can also be used.

Referring now to FIG. 3A, there is shown a cross-sectional view of thepinch clip 2 in an occluding (closed) mode in that the heads 24 of thearms 16 are in a first position in the lower ends 56 of the channels 48in the housing 30. The heads 24 are close enough together so that theypinch the sidewall of the tubing 86 together and prevent fluid flowtherethrough. The clamp 8 is held in this position by the spring 70which is fully extended.

Also shown in FIG. 3A is an adapter 90 which has a first connector 94for fitting within the tubing 86, and a second connector 98 to fitaround the tubing 102. The adapter 90 nests within the base 12 of theclamp 8.

Typically, an infusion set, such as that used with enteral feedingpumps, will have a pair of long sections of tubing formed from amaterial such as PVC, and an interspaced section of tubing made ofsilicone. In the present discussion, the tubing 86 represents thesilicone tubing and the tubing 102 typically represents the proximal PVCtubing positioned upstream from an enteral feeding pump. The siliconetubing 86 is used to pass through an enteral feeding pump because itwithstands the flexing and pulling of the pump rotor better than doesthe PVC tubing 102. An adapter, such as adapter 90, is used to connectthe silicone tubing 86 to each segment of PVC tubing 102.

Referring now to FIG. 3B there is shown a side cross-sectional view ofthe pinch clip 2 in which the clamp 8 is forced into the housing 30. Asthe clamp 8 moves into the housing 30, the heads 24 of the arms 16 areforced apart by the channels 48, so that the arms are held in a second,open position. This leaves the silicone tube 86 unrestricted by theheads 24, thereby allowing solution to flow freely through the tube.

When the clamp 8 is held in the housing 30, the spring 70 is compressedas is shown in FIG. 3B. However, to maintain the position shown in FIG.3B, the pinch clip 2 would be placed into a receptacle as shown in FIG.2, or some other force must be applied to keep the clamp 8 positioned sothat the housing 30 is adjacent the flange 14 of the base 12. Thus, ifthe pinch clip 2 accidently comes out of the receptacle, the spring 70will force the clamp 8 away from the housing 30 and into the positionshown in FIG. 3A. The silicone tube 86 will thereby be occluded, and afree-flow situation cannot develop.

As was discussed regarding FIG. 3A, the adapter 90 nests in the base 12of the clamp 8 and connects the silicone tube 86 with the PVC tube 102.While this is a convenient place to make the transition between thesilicone tube 86 and the PVC tube 102, the change could be made at anyother place along the infusion set.

Referring now to FIG. 4, there is shown an alternate embodiment of thepresent invention. The pinch clip 120 includes a housing 130 with asingle channel 134 formed therein. As with the embodiment shown in FIGS.1-3B, the housing 130 has an open first end 138 for containing asilicone tube 142. The opposing second end 146 is likewise open forreceiving the clamp 150. The clamp 150 has a base 154 with a flange 158and a passage 162 therethrough, similar to the embodiment discussed withrespect to FIGS. 1-3B. However, instead of a pair of arms (such as thoseindicated at 16 in FIGS. 1, 3A and 3B) the embodiment shown in FIG. 4has a single resilient arm 170 which extends from the base 154. A head174 of the arm 170 is moveable between a first, closed position in whichthe head occludes flow through the tube 142 and a second, open position(shown in FIG. 4) in which the head is moved away from the tube so as toallow flow therethrough. A spring 180 is provided to move the base 150away from the housing 120 and to force the head 174 into the first,closed position.

When force is applied to the clamp 150 so as to move the clamp into thehousing 130, the head 174 is pushed away from the tube so as to allowfluid flow therethrough. Thus, the embodiment disclosed in FIG. 4prevents solution flow through the tube 142 by pinching the tube betweenthe arm 170 and a sidewall 186 the side of the housing 130, as opposedto a pair of arms as discussed above.

As with the previous embodiment, the base 154 of the clamp 150 willtypically have a hollow 190 for receiving an adapter 196. The adapter196 enables the silicone tube 142 to be connected to a PVC tube 200.

Each of the components shown in FIG. 4, with the exception of the spring180, the silicone tube 142 and the PVC tube 200 will typically be madeof a thermo-setting plastic material which is semi-resilient. Suchmaterials are inexpensive and inherently disposable.

Referring now to FIG. 5, there is shown another embodiment of thepresent invention. The pinch clip occluder, generally indicated at 200,includes a housing 204 having a first end 208 and a second end 212. Apassage 218 extends along a long axis of the housing 204 from an opening222 in the first end 208 to an opening (not shown) in the second end soas to enable the placement of a tube from a delivery set within thepassage 218.

The pinch clip occluder 200 further includes a plunger 230 disposed soas to intersect the passage 218. Preferably, a long axis of the plunger230 will be perpendicular to the long axis of the housing 204 and thepassage 218. The plunger 230 includes a plunger passage 234 disposedtherein. When the plunger passage 234 and the housing passage 218 are inalignment, fluid flow is allowed through a delivery set (not shown)extending through the housing 204. When the plunger passage 234 and thehousing passage 218 are not in alignment, as shown in exaggeration inFIG. 5, flow through the delivery set is prevented as the tubing of thedelivery set becomes pinched between the plunger 230 and an inner wall240 of the housing 204 and a wall defining the opening (not shown) atthe second end 212.

Referring now to FIG. 5A, there is shown a cross-sectional view of thepinch clip occluder 200 discussed regarding FIG. 5, as well as afragmented tube 250 of a delivery set. The tube 250 is positioned in thepassage 218 to extend along the passage 218. The plunger 230 ispositioned in the housing 204 adjacent the second end 212 so that theplunger passage 234 is in alignment with the housing passage 218. Thus,flow through the tube 250 of the delivery set is not occluded.

As shown in FIG. 5A, the tube 250 has a silicone section 250a and asection 250b made of polyvinylchloride (PVC) or some other suitablematerial. An adapter 252 nests in the opening 222 and connects the twosections 250a and 250b together. Those familiar with delivery sets foruse with enteral feeding pumps and the like will be familiar with suchtubes.

For the plunger 230 to be in such a position in normal usage, someexternal force would need to force the plunger downwardly, as a spring260 biases the plunger passage 234 into a position not in alignment withthe housing passage 218. Thus, when no external pressure is applied tothe plunger 230, the spring 260 forces a bottom wall 238 defining theplunger passage 234 upward so as to pinch closed the tube against anupper wall 270 defining an orifice or opening 274 in the second end 212,and an upper wall 278 defining an orifice or opening 280 in the innerwall 240. The tubing 250 through the plunger passage 234 prevents thespring 260 from displacing the plunger 230 out of the housing 204, andan upper stop 294 prevents the plunger passage 234 from passing beyondan alignment position with the housing passage 218. The upper knob 296disposed above the stop 294 and the lower knob 298 are of similardimensions so that the housing may be placed in an enteral feeding pumpupside down from the position shown in FIGS. 5 and 5A, without affectingfunctionality.

Referring now to FIG. 6, there is shown a pinch clip occluder 200disposed in the housing 300 for an enteral feeding pump. The enteralfeeding pump housing 300 includes a pair of channels 310 and 314 forholding a delivery set tube, such as tube 250 discussed in FIG. 5A. Inuse, the tube is placed in one channel 310, wrapped about a motor unit(not shown) which is placed in the opening 320, and then positioned inthe second channel 314. If the tube is not properly wrapped about themotor unit and placed in the channels 310 and 314 a free-flow conditionmay develop. However, the present invention prevents such a situationfrom developing.

As shown in FIG. 6, the pinch clip occluder 200 is positioned along thechannel 310. The plunger 230 is positioned so as to occlude flow througha tube disposed in the channel 310. To overcome the biased closedposition of the plunger 230, an external force must be applied. This istypically done by closing a cover 330 which is connected to the housing300. When closed, the cover 330 applies downward force on the plunger230 so that the plunger passage 234 and the housing passage are inalignment. However, if the tube of the delivery set is not properlyloaded in the channels 310 and 314, the cover is unable to close and theplunger 230 is not forced downwardly. Thus, the pinch clip occluder 200prevents flow through the enteral feeding pump unless the delivery setis properly loaded. Once the cover 330 is closed, the enteral feedingpump may function normally.

In the manner described, a pinch clip occluder for delivery sets isprovided. In one embodiment, the pinch clip occluder utilizes a clampingmechanism with at least one arm nested at least partially within ahousing which serves as an adjustment mechanism by moving the armbetween a position in which the arm occludes flow through and infusionset, and a position in which it allows free-flow through the infusionset. In another embodiment, a moveable plunger which has a plungerpassage alignable with a housing passage occludes flow through thehousing unless an external pressure is applied.

It is to be understood that the above-described arrangements are onlyillustrative of the application of the principles of the presentinvention. Numerous modifications and alternative arrangements may bedevised by those skilled in the art without departing from the spiritand scope of the present invention. The appended claims are intended tocover such modifications and arrangements.

What is claimed is:
 1. Apparatus for selectively controlling flowthrough one or more tubes of an infusion delivery set, the apparatuscomprising:a pump housing having:at least one channel disposed thereinfor receiving a tube of the delivery set, a cover means for holding thetube of the delivery set within the housing, the cover means having anopen position wherein the delivery set can be removed from the at leastone channel, and a closed position, wherein the delivery set cannot beremoved from the at least one channel, and a void formed therein forreceiving an occluder means; an occluder means nestible within the pumphousing, the occluder means comprising:an occluder housing having anopen first end and an open second end and a passage therethroughextending from the open first end to the open second end for receivingthe tube of the delivery set; flow restriction means disposed at leastpartially within the housing and moveable between a first position inwhich the flow restriction means occludes flow through the tube of thedelivery set and a second position in which the flow restriction meansdoes not occlude flow through the tube; and biasing means disposedadjacent the housing and the flow restriction means for biasing the flowrestricting means into the first position; and wherein the cover meansis disposed to contact and move the flow restriction means into thesecond position when the cover means is moved into the closed position.2. The apparatus of claim 1, wherein the flow restriction meanscomprises at least one arm slidably movable between a first position inwhich the at least one arm pinches the tube so as to prevent flowtherethrough, and a second position in which the at least one arm nolonger pinches the tube.
 3. The apparatus of claim 1, wherein the flowrestriction means comprises a plunger having a plunger passagetherethrough, the plunger being movable between a first position inwhich the plunger passage is not in alignment with the passage of thehousing so as to occlude flow through the tube passing through thepassage of the housing, and a second position in which the plungerpassage is in alignment with the passage of the housing so as to allowflow though said tube passing through the passage of the housing.
 4. Theapparatus of claim 1, wherein the occlusion means further comprises anadapter disposed adjacent the occluder housing for connecting two tubesections of a delivery set, one of said two tube sections being at leastpartially disposed in the occluder housing.
 5. The apparatus of claim 1,wherein the at least one channel in the pump housing defines a passage,and wherein the passage of the occluder means is in alignment with thepassage of the pump housing when the occluder means is nested in thepump housing.
 6. The apparatus of claim 5, wherein flow through thedelivery set is precluded when the passage of the occluder means is notin alignment with the passage of the pump housing.
 7. The apparatus ofclaim 1, wherein the flow restriction means comprises a plunger having along axis, and wherein the occluder housing has a long axis disposedperpendicular to the long axis of the plunger.
 8. The apparatus of claim7, wherein the passage in the occluder means has a long axis which isdisposed generally perpendicular to the plunger.
 9. The apparatus ofclaim 1, Wherein the pump housing has a pair of channels disposedtherein for holding the delivery set.
 10. The apparatus of claim 1,wherein the plunger further comprises a knob disposed thereon oppositethe occluder housing for nesting within the void in the pump housingwhen the occluder is disposed in the void with the plunger extendingdownwardly.
 11. The apparatus of claim 1, wherein the occluder furthercomprises a knob extending downwardly from the occluder housing so as tonest within the void in the pump housing when the occluder is disposedtherein right side up.
 12. An apparatus for preventing free flow in atube of a delivery set when used with a pump, the apparatus comprising:apump housing means for holding a tube of the delivery set, the pumphousing means having at least one channel disposed therein for receivingthe tube, and a cover means for selectively holding the tube within theat least one channel, the cover means having an open position whereinthe tube can be removed from the at least channel, and a closedposition, wherein the tube is held within the at least one channel;occluder means for selectively preventing flow through the tube, theoccluder means comprising:an occluder housing having an open first end,an open second end and a passage extending from the open first end tothe open second end for holding a tube of an infusion set; and plungermeans disposed generally transverse to the passage of the occluderhousing for selectively occluding flow through the tube, the plungermeans comprising a plunger passage movable between a first positionwherein the plunger passage is not in alignment with the passage throughthe occluder housing so as to occlude flow through the tube, and asecond position wherein the plunger passage is in alignment with thepassage through the occluder housing so as to allow flow through thetube; and wherein the cover means is disposed so that when the covermeans is moved into the closed position, the cover means contacts andmoves the plunger means from the first position, wherein the plungerpassage is not in alignment with the passage through the occluderhousing, to the second position, wherein the plunger passage is inalignment with the passage through the occluder housing.
 13. Theapparatus of claim 12, wherein the occluder means further comprisingbiasing means for biasing the plunger means into the first position. 14.The apparatus of claim 12, wherein the occluder housing comprises atleast one wall defining an orifice disposed about the passage adjacentthe plunger means such that when the plunger means is disposed withinthe first position, the tube extending through the passage of theoccluder housing and the plunger passage is pinched between the plungerand the at least one wall so as to prevent flow through the tube. 15.The apparatus of claim 12, wherein the occluder housing has a first endand a second end, each end having an opening formed therein, and aninner wall disposed between the first end and the second end.
 16. Theapparatus of claim 12, wherein the plunger means has a long axis, andwherein the occluder housing has a long axis perpendicular to the longaxis of the plunger means.
 17. The apparatus of claim 12, wherein theplunger means has a knob disposed thereon on a side opposite theoccluder housing for nesting within the void of the pump housing. 18.The apparatus of claim 12, wherein the occluder further comprises a knobextending downwardly from the occluder housing for nesting in the voidin the pump housing.
 19. Apparatus for selectively controlling flowthrough one or more tubes of an infusion delivery set, the apparatuscomprising:a pump housing having:at least one channel disposed thereinfor receiving a tube of the delivery set, a cover means for holding thetube of the delivery set within the housing, the cover means having anopen position wherein the delivery set can be removed from the at leastone channel, and a closed position, wherein the delivery set cannot beremoved from the at least one channel, and a void formed therein forreceiving an occluder means; an occluder means nestible within the pumphousing, the occluder means comprising:an occluder housing having anopen first end and an open second end and a passage therethroughextending from the open first end to the open second end for receivingthe tube of the delivery set, the occluder housing further comprising aknob disposed so as to extend downward from the housing for dispositionin the void in the pump housing; flow restriction means disposed atleast partially within the housing and moveable between a first positionin which the flow restriction means occludes flow through the tube ofthe delivery set and a second position in which the flow restrictionmeans does not occlude flow through the tube; and biasing means disposedadjacent the housing and the flow restriction means for biasing the flowrestricting means into the first position; and wherein the cover meansis disposed to contact and move the flow restriction means into thesecond position when the cover means is moved into the closed position.